U.S. patent number 6,945,961 [Application Number 10/611,389] was granted by the patent office on 2005-09-20 for injection device.
This patent grant is currently assigned to Novo Nordisk A/S. Invention is credited to Steffen Hansen, Thomas Dedenroth Miller, Claus Schmidt Moller.
United States Patent |
6,945,961 |
Miller , et al. |
September 20, 2005 |
Injection device
Abstract
An injection device having an incremental clicking mechanism
providing the user with an indication of the number of doses being
set. For handling different types of medicaments having different
dose volumes in the same type of injection device it is beneficial
to provide an additional clicking mechanism which is easy
changeable. The clicking mechanism is preferably a curved track
provided between the dose setting member and a non-rotatable
clicker element.
Inventors: |
Miller; Thomas Dedenroth
(Copenhagen, DK), Moller; Claus Schmidt (Fredensborg,
DK), Hansen; Steffen (Hillerod, DK) |
Assignee: |
Novo Nordisk A/S (Bagsvaerd,
DK)
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Family
ID: |
32033866 |
Appl.
No.: |
10/611,389 |
Filed: |
July 1, 2003 |
Foreign Application Priority Data
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Jul 10, 2002 [DK] |
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2002 01084 |
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Current U.S.
Class: |
604/207; 604/208;
604/211; 604/218; 604/223; 604/224; 604/232 |
Current CPC
Class: |
A61M
5/31525 (20130101); A61M 5/31553 (20130101); A61M
5/31558 (20130101); A61M 5/3156 (20130101); A61M
5/31585 (20130101); A61M 5/3146 (20130101); A61M
5/31535 (20130101); A61M 5/31541 (20130101); A61M
5/31595 (20130101); A61M 2005/31518 (20130101); A61M
2205/581 (20130101) |
Current International
Class: |
A61M
5/315 (20060101); A61M 005/00 () |
Field of
Search: |
;604/232,220,228,229,71,246,181,186-187,207-211,218,223-225
;222/309,390,391 |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
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554996 |
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Aug 1993 |
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EP |
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702970 |
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Mar 1996 |
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EP |
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WO 01/54757 |
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Aug 2001 |
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WO |
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WO 01/83008 |
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Nov 2001 |
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WO |
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Primary Examiner: Lucchesi; Nicholas D.
Assistant Examiner: Williams; Catherine S.
Attorney, Agent or Firm: Began, Esq.; Marc A. Green, Esq.;
Reza Bosk, Esq.; Richard W.
Parent Case Text
CROSS REFERENCE TO RELATED APPLICATIONS
This application claims priority under 35 U.S.C. 119 of Danish
application no. PA 2002 01084 filed Jul. 10, 2002, and U.S.
provisional application No. 60/401,545 filed Aug. 6, 2002; the
contents of both are fully incorporated herein by reference.
Claims
What is claimed is:
1. An injection device having a housing accommodating a cartridge
containing medicine sufficient for a number of dosed injections,
which doses are injected by advancing a piston rod forward inside
the cartridge, comprising: a dose setting and injection mechanism,
comprising an incremental feedback mechanism, a rotatable dose
setting member operationally coupled to the dose setting and
injection mechanism for setting up a dose to be injected, and an
injection button operationally coupled to the dose setting and
injection mechanism and by which the dose setting and injection
mechanism can be activated for advancing the piston rod forward to
press out the set dose through a conduit connected to said
cartridge, wherein: an additional clicking means is provided
between the rotatable dose setting member and a non-rotatable
clicker element, and wherein the additional clicking means provides
incremental clicks corresponding to a dose volume, the clicking
means comprises a curved track provided as a part of the rotatable
dose setting member wherein curved track engages the non-rotatable
clicker element provided on or as a part of the injection device,
the curved track is provided with a number of spared indentations,
there are 5 to 60 equally spaced indentations, and an air shot
indentation is provided between the first equally spaced
indentations.
2. An injection device having a housing accommodating a cartridge
containing medicine sufficient for a number of dosed injections,
which doses are injected by advancing a piston rod forward inside
the cartridge, comprising: a dose setting and injection mechanism,
comprising an incremental feedback mechanism, a rotatable dose
setting member operationally coupled to the dose setting and
injection mechanism for setting up a dose to be injected, and an
injection button operationally coupled to the dose setting and
injection mechanism and by which the dose setting and injection
mechanism can be activated for advancing the piston rod forward to
press out the set dose through a conduit connected to said
cartridge, wherein: an additional clicking element is provided
between the rotatable dose setting member and a non-rotatable
clicker element, and wherein the additional clicking element
provides incremental clicks corresponding to a dose volume, the
clicking element comprises a curved track provided as a part of the
rotatable dose setting member wherein curved track engages the
non-rotatable clicker element provided on or as a part of the
injection device, the curved track is provided with a number of
equally spaced indentations, there are more than 2 spaced
indentations, and an air shot indentation is provided between the
two first equally spaced indentations.
Description
THE TECHNICAL FIELD OF THE INVENTION
The invention relates to injection devices of the kind comprising a
housing accommodating a cartridge, a dose setting and injection
mechanism, a rotatable dose setting member coupled to the dose
setting and injection mechanism, and an injection button coupled to
the dose setting and injection mechanism and by which a piston rod
drive can be activated for advancing the piston forward to press
out a set dose through a conduit connected to the cartridge.
DESCRIPTION OF RELATED ART
A prior art injection device of this kind is disclosed in WO
01/83008. This injection device comprises of three basic parts; a
dose setting and injection mechanism, a dose setting member and an
injection button.
The dose setting and injection mechanism of this prior art
injection device is best shown in FIG. 4 of WO 01/83008. When a
dose is being set, the coupling ring (29) is rotated by the arm
(32). During this rotation the barb (40) rides over the barbs (41)
of the driver (27) which produces a clicking and audible sound. At
the same time the bulging ends (43, 44) of the coupling ring (29)
also makes an audible sound by riding over the barbs (45) on the
inside surface of the rod guiding part (20). The driver (27) and
the guiding part (20) are both provided with the same number of
barbs, such that the produced audible sounds amplify each other.
The barbs also work as incremental clicks indicating the number of
set doses. The number of barbs or clicks are set to equal the dose
scale of the injection device, such that one barb or click is
dedicated each single dose setting. For the particular injection
device shown in WO 01/83008 the number of barbs or clicks is 60
such that the scale, which scale indications correlate with the
barbs or clicks, resembles the scale of an ordinary clock bearing
60 scale indications on one full circle. All though in same cases
the full circle is not used and henceforth there are fewer scale
indications.
This prior art injection device is to be used by diabetics needing
regular injections of insulin. The distance between each barb is
therefore set to correlate with one international unit of insulin
(1 IU). In this way the user will feel and hear one incremental
click for each international unit being set. Insulin is typically
made with 100 international units (IU) pr. millilitre of
insulin.
DESCRIPTION OF THE INVENTION
This prior art injection device has proven itself very attractive
to people suffering from diabetes. Due to the number of barbs, the
prior art injection device is only suitable for one particular type
of fluid medicament, since the tactile guidance is incorporated in
the distance between the barbs and in the number of barbs. The
prior art injection device is particular suitable for a fluid
medication which are injected in a dose regimen requiring fine
adjustment of the dose setting.
If an injection device of the type described in WO 01/83008 is to
be used for other types of medicaments which has to be injected in
a different dose volume e.g. with larger increment dose volumes, it
will be necessary to redesign at least the dose setting and
injection mechanism, such that the number of barbs of the new dose
setting and injection mechanism correlates with the size of these
new dose volumes.
This is however rather cumbersome, since it requires a different
injection device, or at least a different dose setting and
injection mechanism for each type of medicament.
The present invention aims to solve the problem of handling
different types of medicaments being injected in different dose
volumes or in different concentrations by providing the injection
device with additional clicking means provided between the
rotatable dose setting member and a non-rotatable clicker element,
which clicking mechanism provides clicks that corresponds to a new
dose volume, as defined in claim 1.
The general concept of the present invention is to provide an
additional clicking mechanism which overrides the general clicking
mechanism of the injection device. This has the advantages that the
tactile and audible feedback of the injection device can be easily
changed with out changing the underlying injection mechanism.
An injection device for insulin is usually provided with a tactile
and audible feedback that correlates to international units of
insulin, such that the user is provided with one click for each
international unit being set.
According to claim 1, the injection device can now be utilized for
a number of different fluid medicaments or concentrations of
medicaments only by changing the dose setting member as long as the
additional dose setting clicks provided from the interaction
between the dose setting member and the non-rotatable clicker
element is a multiplication of the underlying clicks provided by
the dose setting and injection mechanism.
In this way the same injection device with the same dose setting
and injection mechanism can be utilized for a number of different
fluid medicaments or concentrations of medicaments only by changing
the dose setting member.
When as disclosed in claim 2, the clicking means comprises a curved
track provided as a part of the rotatable dose setting member,
which curved track engages a non-rotatable clicker element provided
on or as a part of the injection device, it is ensured that the
distance between the indentations making up the curve can be
designed quit freely.
When the curved track is provided on the periphery of the rotatable
dose setting member as specified in claim 3 and the clicker element
is a protrusion provided either on the housing as specified in
claim 4 or on the dose setting and injection member as specified in
claim 5, a very clear and distinct tactile guidance is
obtained.
When as disclosed in claim 6, the protrusion is carried on a
flexible arm, it is ensured that the rotatable dose setting member
can be easy rotated.
The spaced indentations specified in claim 7 define the size of the
dosage. These indentations should be a multiplication of the
underlying smaller incremental clicks provided by the interaction
between the barbs on the coupling ring and the outer toothing on
the driver.
If the underlying incremental clicks represent international units
of insulin it will be beneficial if a full circle represents 60
units. If the doses of medication to be injected by the new
injection device is e.g. five time higher, the number of
indentations then needs to be 12 indentations on a full circle.
It is however not necessary to provide the full number of
indentations. With some medicaments there are a limit to the number
of doses that can be injected at one time thus it is not necessary
to provide more indentations than the maximum allowed number of
doses.
As specified in claim 8, the preferred range of indentations is
from 5 to 60. 60 indentations are preferred when the injection
device is to be used for U 100 insulin. In this case the additional
clicking will follow and amplify the underlying injection
mechanism.
If one new dosage equals 10 international units of insulin a total
of 6 indentations will be needed on a full circle. Prior to
injecting the fluid medicament it is customary to make a so called
air shot in order to empty the ampoule for air trapped inside the
ampoule. An air shot is usually done by holding the device in a
vertical upright position and deliver one unit. However, if one
indentation representing one new dose of medicament contains 10
international units a large amount of medicament will be wasted. It
is therefore preferred as specified in claim 9 to provide an air
shot indentation located between the first and the second ordinary
indentation. The size of the air shot defined by the location of
the air shot indentation can be freely designed.
When as disclosed in claim 10, the rotatable dose setting member is
provided with a scale where the indications correlate to the
indentations, it is ensured that the user beside the tactile and
the audible incremental feedback also is provided with a visual
indication.
BRIEF DESCRIPTION OF THE DRAWINGS
The invention will be explained more fully below in connection with
a preferred embodiment and with reference to the drawings in
which:
FIG. 1 Shows an exploded view of the prior art injection device
FIG. 2 Shows an exploded view of the dose setting and injection
mechanism of the prior art injection device.
FIG. 3 Shows a schematically top view of the dose setting and
injection mechanism of the prior art injection device.
FIG. 4 Shows a schematically bottom view of the dose setting and
injection mechanism of the prior art injection device.
FIG. 5 Shows an exploded view of the dose setting and injection
mechanism according to the invention.
FIG. 6 Shows a cross sectional view through the dose setting and
injection mechanism according to the invention.
FIG. 7 Shows the dose setting and injecting mechanism according to
the invention with the dose setting button.
FIG. 8 Shows the dose setting button according to an embodiment of
the invention
The figures are schematic and simplified for clarity, and they just
show details, which are essential to the understanding of the
invention, while other details are left out. Throughout, the same
reference numerals are used for identical or corresponding
parts.
DETAILED DESCRIPTION OF EMBODIMENT
FIGS. 1-4 shows the dose setting and injection mechanism 1 known
from WO 01.83008.
The injection device 1 disclosed in FIG. 1 comprises a dose and
injection mechanism 2 insertable into a housing 3. Also insertable
into the housing 3 is the cartridge 4 containing the fluid
medicament. A dose setting button 5 and an injection button 6 is
connected to the dose and injection mechanism 2 inside the housing
3. The injection button 6 is provided with a toothed rack 7, which
operates the dose and injection mechanism 2 to deliver a dose.
This prior art dose setting and injection mechanism 2 comprises a
rod guiding part 8 in which a flexible piston rod 9 is guided. The
rod guiding part 8 has a slot 10 into which the toothed rack 7 of
the injection button 6 is guided. The flexible piston rod 9 is
driven by a first gear wheel 11, which again is driven by the
hub-wheel 12 of the second gear wheel 13. The second gear wheel 13
is made up from an outer toothed wheel 14 which is integral with
the hub-wheel 12. The outer toothed wheel 14 is driven by the
toothed axis 15 on the driver 16. This driver 16 has an outer
tooting 17, which is located inside a coupling ring 18. The
coupling ring 18 is provided with a coupling ring wheel 19, which
is driven by the toothed rack 7 of the injection button 6 when a
dose is being injected.
The coupling ring wheel 19 is connected to coupling ring 18 through
a rigid part 20 and a more flexible part 21. The coupling ring 18
has on its inside surface one or more barbs 22, which interconnects
with the outer tooting 17 of the driver 16, such that the driver 16
is driven by the coupling ring 18 in one direction, but not
necessarily in the opposite direction.
A protrusion 23 provided on an inside surface of the rod guiding
part 8 prevents the driver 16 from rotation in one direction. The
direction in which the driver 16 can move freely is the direction
in which the piston rod 9 is moved forward in the cartridge 4.
An arm 24 is at the centre 25 connected to the central portion of
the rod guiding part 8. On the other end, the arm 24 is equipped
with a cam 26 interacting with a notch 27 provided at the rim of
the coupling ring 18. The arm 24 also has a depression 28, which is
operational connected to the dose setting button 5, such that the
arm 24 is rotated around the central portion of the rod guiding
part 8 when the dose setting button 5 is rotated to set a dose.
A second arm 29 is situated parallel to the first arm 24 and is
permanently connected thereto through a flexible beam. The second
arm 29 bears on its backside a not shown cam, which cam is movable
locked in the spiral shaped track of the driver 16. In this way,
the number of rotations the driver 16 can perform relatively to the
second arm 29 is limited to the length of the spiral shaped track.
The total length of this track is adapted to the total amount of
medicine in the cartridge 4 thereby ensuring that a dose larger
than the amount of medicine remaining in the cartridge 4 can not be
set.
When operating the injection device, the dose is set by turning the
dose setting button 5 in the clockwise direction. The arm 24, which
is operational connected to the dose setting button 5 rotates
simultaneously. The notch 26 on the arm 24 rotates the coupling
ring 18 too. Since the coupling ring wheel 19 interacts with the
toothed rack 7 of the injection button 6, this injection button 6
is lifted away from the housing 3. Due to the protrusion 23, the
driver 16 is prevented from rotating.
When the coupling ring 18 rotates, the bulging ends 30, 31 rides
over the toothed surface 32 of the rod guiding part 8. The
injection device shown in FIGS. 1-4 is to be used by diabetics
needing regular injections of insulin. Therefore the distance
between each of the indentations making up the toothed surface 32
corresponds to one international unit of insulin (1 IU). In this
way the user can feel every increment being set when rotating the
dose setting button 5. In addition an audible sound is produced
when the bulging ends 30, 31 ride over the toothed surface 32. The
incremental feeling and the incremental sound follows the number of
indentations on the toothed surface 32.
The barb 22 on the coupling ring 18 rides over the outer toothing
17 of the driver 16 when a dose is set, which adds to the
incremental feeling and to the incremental sound.
When delivering the set dose, the injection button 6 is pressed
home. The toothed rack 7 of the injection button 6 then rotates the
coupling ring wheel 19. The barb 22 interacts with the outer
toothing 17 of the driver 16 hence rotating the driver 16 in the
anti-clockwise direction. The rotation of the driver 16 is
transmitted through the second gear wheel 13 to the first gear
wheel 11, which first gear wheel 11 engages the piston rod 9.
Rotation of the first gear wheel 11 causes the piston rod 9 to move
forward inside the cartridge 4 thereby expelling the set dose of
medicine through a not shown conduit connected to the distal end of
the cartridge 4.
If a set dose is regretted, the dose setting member 5 is rotated in
the anti clockwise direction. Due to the flexible part 21 of the
coupling ring 18, the coupling ring 18 expands outwardly when
rotated anti clockwise, allowing the barb 22 to slide over the
outer toothing 17 of the driver 16. Hence the driver 16 is not
affected by this backward rotation of the coupling ring 18.
FIGS. 5-6 discloses a dose setting and injecting mechanism 102
according to the invention. The toothed rack 107 of the injection
button 106 engages the coupling ring wheel 119 through a slot in
the rod guiding part 108. The coupling ring wheel 119 is integral
with the coupling ring 118, which coupling ring 118 engages the
driver 116. This engagement is made by one or more barb 122 located
on the inside surface of the coupling ring 118 engaging the outer
toothing 117 of the driver 116.
A protrusion 123 provided on an inside surface of the rod guiding
part 108 prevents the driver 116 from rotation in one direction.
The direction in which the driver 116 can move freely is the
direction in which the piston rod 109 is moved forward inside the
cartridge 104.
On the flipside of the rod guiding part 108, the toothed axis 115
of the driver 116 engages the second gear wheel 113. The second
gear wheel 113 engages the first gear wheel 111 which transmits the
rotational movement to the piston rod 109.
The inside surface 132 of the rod guiding part 108 is left as a
smooth surface without any indentations. The bulging ends 131, 132
of the coupling ring 118 slides along this smooth inside surface
132 when a dose is set. As a result of this the incremental
feedback delivered to the user from the dose setting and injection
mechanism 102 of the injection device 1 is very gentle. Only a very
silent clicking sound coming from the barbs 122 sliding over the
outer toothing 117 of the driver 116 is heard when a dose is
set.
Instead of the incremental guidance being a part of the dose
setting and injecting mechanism 102 alone, this guidance is now
overridden by the interaction between the dose setting button 105
and a non-rotatable clicker element 136, as will be explained in
the following.
The dose setting button 105 is on the surface pointing towards the
rod guiding part 108 provided with a number of indentations 135.
The rod guiding part 108 is provided with a protrusion 136, which
interacts with the dose setting button 105 when the injection
device 1 is assembled. The protrusion 136 is located on a resilient
arm 137 which is integral with the rod guiding part 108, but could
as well be located on the housing.
When the dose setting button 105 is rotated the interaction between
the indentations 135 of the dose setting button 105 and the
protrusion 136 will provide the user with a tactile feedback
containing both an incremental click feeling and an incremental
click sound.
Even if the inside surface 132 of the rod guiding part 108 is
toothed as known from the prior art, the interaction between the
indentations 135 of the dose setting button 105 and the protrusion
136 will override the incremental clicks here provided, such that
the user will feel the incremental clicks of the dose setting
button 105 stronger than the incremental clicks provided by a
toothing of the surface 132.
As shown in FIGS. 7-8, the incremental indentations 135 of the dose
setting button 105 is preferably located on a circular curved track
138 provided adjacent the upper part 139 of the dose setting button
105. The upper part 139 is also provided with a finger grip 140, by
which the user can grip when setting up the dose to be
injected.
The carrier 143 provided on the backside of the dose setting button
105 connects the dose setting button with the coupling ring 118
such that the coupling ring 118 rotates with the dose setting
button 105.
The distance between the indentations 135 determines the size of
the dose volume to be set. With the distance between the
indentations 135 shown in FIG. 7 some rather large dose volumes are
set. Preferably the number of the indentations 135 should be a
multiplication of the number of teeth provided on the outer
toothing 117 of the driver 116. If the injection device e.g. is
made with 60 teeth on the outer toothing 117, there should be 2, 3,
5, 6, 10, 12, 15, 20, 25, 30, or 60 indentations 135 such that the
overriding dose setting clicks works with the underlying dose
setting mechanism on the full circle.
It is however possible to have a number of indentations which are
not a multiplication of the numbers of teeth on the driver 116 as
long as one dose setting on the dose setting button 105 correlates
with a full number of teeth on the outer toothing 117 of the driver
116. In such case however the full circle can not be utilized.
When a large distance between the indentations 135 corresponding to
large dose volumes, is used, it is beneficial to provide a separate
air shoot click 141 provided between the first and the second of
the indentations 135. In this way, the user can use this small air
shoot click 141 when making an air shoot instead of having to use a
full dose volume.
The distance between the indentations 142 of the dose setting
button 105, is in FIG. 8 shown as a short distance corresponding to
a small dose volume. The specific dose setting button 105 shown in
FIG. 8 has 60 indentations 142 on one full circle, such that the
scale can be made to resemble that of an ordinary egg timer such as
shown in U.S. Pat. No. 5,947,934.
Some preferred embodiments have been shown in the foregoing, but it
should be stressed that the invention is not limited to these, but
may be embodied in other ways within the subject matter defined in
the following claims.
Listing of parts 1 Injection device 2 Dose setting and injecting
mechanism 102 3 Housing 4 Cartridge 5 Dose setting button 105 6
Injection button 106 7 Toothed rack 107 8 Rod guiding part 108 9
Piston rod 109 10 Slot 11 First gear wheel 111 12 Hub-wheel 13
Second gear wheel 113 14 Outer toothed wheel 15 Toothed axis 115 16
Driver 116 17 Outer toothing of Driver 117 18 Coupling ring 118 19
Coupling ring wheel 119 20 Rigid part 21 Flexible part 22 Barbs 122
23 Protrusion 123 24 Arm 25 Centre of arm 26 Cam 27 Notch 28
Depression 29 Second arm 30, 31 Bulging ends (of coupling ring)
131, 132 32 inside surface 132 133 134 Indentations 135, 142
Protrusion 136 Flexible arm 137 Curved track 138 Upper part (of
Dose setting button) 139 Finger grip 140 Carrier 143
* * * * *